Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval

FDA Class 3 ·BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0

Helmet, Cranial, For Protective Use

FDA classification

FDA Class 1 ·Helmet, Cranial, For Protective Use

CONDUCTOR (CONDUCT OR)

FDA registration

PENTAX of America, Inc.·1 product·🇺🇸 United States

Halcyon

FDA registration

Varian Medical Systems China Co., Ltd.·2 products·🇨🇳 China

Halcyon, Ethos Radiotherapy System

FDA registration

Varian Medical Systems China Co., Ltd.·1 product·🇨🇳 China

Halcyon Ethos Radiotherapy System

FDA registration

Varian Medical Systems China Co., Ltd.·1 product·🇨🇳 China

Changsha Contec Yixin Biotechnology Co.,Ltd.

Manufacturer

🇨🇳 China

Apharm S.r.l.

Manufacturer

🇮🇹 Italy

DNA Diagnostic

Manufacturer

🇩🇰 Denmark

Halotech DNA

Manufacturer

🇪🇸 Spain·5 Basic UDI-DIs·5 Devices

da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30

FDA registration

Intuitive Surgical-Fosun Medical Technology (Shanghai) CO., LTD. C/O Shanghai HMG Medical Supply Chain Service Co.,Ltd.·2 products·🇨🇳 China

da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30

FDA registration

INTUITIVE SURGICAL-FOSUN MEDICAL TECHNOLOGY (SHANGHAI) CO., LTD.·2 products·🇨🇳 China

Ada Health GmbH

Manufacturer

🇩🇪 Germany·4 Basic UDI-DIs·26 Devices

DNA Genotek Inc.

Manufacturer

🇨🇦 Canada·10 Basic UDI-DIs·31 Devices·5 Importers

Integrated DNA Technologies

Manufacturer

🇺🇸 United States

Advantis Medical Imaging Single Member P.C.

FDA registration

Advantis Medical Imaging Single Member P.C.·1 product·🇬🇷 Greece

Zimmer Biomet

FDA registration

TOTEX MANUFACTURING INC·1 product·🇺🇸 United States

Fluorescent Antibody (Tissue) Conjugate

FDA UDI

Diasorin Inc.·08056771601047·

Fluorescent nDNA Test System

FDA UDI

IMMUNO CONCEPTS INC·M7490302611·nDNA FA Titratable Control - 2 x 0.5 ml

Kallestad

FDA UDI

Bio-RAD Laboratories, Inc.·00847865001564·Kallestad Crithidia luciliae 8 Well Slides